By Louis Garguilo, Chief Editor, Outsourced Pharma
A vote for now-President Joe Biden was a vote to give your IP away.
Feigned surprise at Biden’s agreement with the World Trade Organization (WTO) that the pharma industry should waive its IP protection for the coronavirus vaccines, is rather unbecoming.
Such writing was all over the campaign walls.
But first we’ve two intermediate steps to reach that destination.
We need to document the prevailing industry reaction regarding Biden’s waiver wackiness.
Thankfully, that reaction was swift and direct, and can be represented by two public statements.
First from The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO, Stephen J. Ubl:
“In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”
Outsourced Pharma readers know, amongst so much more, a great deal of that “confusion” will land in facilities at CDMOs producing the vaccines, a specific topic we will cover subsequently.
Ubl had more to say:
“This change in longstanding American policy will not save lives … This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores.”
The second representative reaction comes from a piece written by former-FDA commissioner Scott Gottlieb and former Director for Medical and Biodefense Preparedness at the National Security Council, Luciana Borio:
“The Biden administration’s support for breaking vaccine patents is a bad precedent that would do no immediate good and substantial long-term harm.”
“The Biden administration caved to pressure at the World Trade Organization (WTO) to support waiving intellectual-property protections for Covid vaccines.”
Focus On IP Law
Our second step down this path to understanding what is happening here addresses the substance: the actual IP agreements and regulations that govern your work.
For this, I spoke to Troy Groetken, a patent lawyer at McAndrews, Held & Malloy, Ltd., a full-service intellectual property and technology law firm. Groetken advises a variety of biopharma organizations, and also owns a B.S. in Pharmacy.
His initial reaction to hearing of the IP giveaway?
“This is shortsighted in that the administration had multiple other ways to address the issue and achieve their goals, rather than just immediately agree with other countries that we need to use the TRIPS agreement to waiver IP rights. I don't find that advantageous at all.”
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between member nations of the WTO.
This, in effect, is the hammer with which Biden and other international progressives wants to break your IP.
Groetken says it is unnecessary.
“The pharma industry has already granted ample access to information,” and to a large degree, “that's why we have in fact been able to successfully fight COVID-19 so quickly.”
“We have other patent-sharing pledges, including C-Tap, to allow people to take advantage of these advanced technologies, and bring up their capabilities. But without forfeiting that IP.”
C-TAP stands for the COVID-19 Technology Access Pool, launched by the WHO in a “call to action” to voluntarily share knowledge, IP and data for COVID-19. It has provided a means to accelerate the development of products, the scale-up of manufacturing, and the removal of barriers to make products globally.
“Moreover, we already saw in the previous administration with the Defense Production Act, you can forge ahead, and through that particular step continue to increase our total production of vaccines,” says Groetken.
The Defense Production Act is a 1950 law allowing the U.S. government to award contracts that take priority over all others for national defense. At the start of the pandemic, President Trump initiated use of this act, and that utilization continues under the Biden administration.
But here’s the main question I want to ask Groetken:
Does the U.S. President actually have the authority to waive – water down or alter – protections gained through legal and regulatory law, and officially granted to U.S. biopharma companies?
“That's a very good question,” Groetken says. “The answer is pursuant to that TRIPS agreement in WTO. In times of crisis, you can create a situation where the government asks you to waive your IP.”
Or takes it away, it appears. Not the answer I was hoping for.
Back To Voting
Some are dubbing this “political theatre,” and “playing to the progressive base” in the democratic party.
Unfortunately, it isn’t a play, or a game.
It’s your IP. And governance by organizations outside the U.S.
Groetken assures me the biopharma companies he works with are taking this very seriously.
“We have to take it seriously. Any time an administration or a government entity wants to take a position, or create some particular outcome, it impacts what we're trying to do as businesses and an industry – and not only today, but tomorrow, right?
“We now know that this is the approach the administration is going to have, maybe with other vaccines in the future. I know of several vaccine manufacturers who are saying to themselves, ‘Could we be the next target? The next business that's going to be impacted?’
“And we know for vaccine manufacturers specifically, the development and manufacturing process takes years, and there are various rounds of investments. What does this say to their various investors, when those investors understand a large chunk of your value as a company will be your intellectual property?
“Moreover, how can you possibly implement this outcome to even allow the access to the IP in question?”
And because there is no good answer to his last question, and with the outrage from the industry duly raised, Groetken (like many others) suspects the administration will modify its position, further utilize the Defense Production Act, and focus on “distribution or other meaningful activities to truly achieve their goal.”
“That is where we should be focused,” adds Groetken, “as well as further incentivizing companies, not disincentivizing them.”
His final thought: “Why did Biden immediately come out and make this kind of statement? It really does not achieve anything.”
Arguably, politics has never played a bigger role in our (global) biopharma industry.
And unfortunately, the turmoil of the China-borne coronavirus, and the U.S. presidential election of 2020, continue to find new ways to impact us.
Incalculable hard work, rewarded through a system of national capitalism, built the pharmaceutical industry that has been able to take on the evils of this virus.
Let’s vote to keep that system in place. And keep our decisions on these shores, so we can also logically and effectively help those on others.